Xarelto victim alleges scientific data downplayed

The number of filed Xarelto lawsuits continues to grow primarily on two fronts. First, the Philadelphia Court of Common Pleas established a mass tort docket in January where more than 170 Xarelto lawsuits are pending. Second, a panel of federal judges centralized federal Xarelto lawsuits in December before the U.S. District Court for the Eastern District of Louisiana for uniform pretrial management. As of April 15, more than 400 Xarelto lawsuits were pending before the Louisiana federal trial court.

Xarelto lawsuits generally allege that the plaintiffs suffered from severe bleeding or related injury due to their use of the anticoagulant Xarelto (rivaroxaban). Plaintiffs also claim that the defendants, including the manufacturer, Janssen Pharmaceuticals, did not adequately warn health care professionals and potential patients about the bleeding, which can be severe, uncontrollable and, in some cases, either life-threatening or fatal.

Although efforts are underway to find an antidote for Xarelto bleeding, at this point there is no reversal agent. The U.S. Food and Drug Administration initially approved Xarelto in 2011.

One of the more recent state court lawsuits was added to the Philadelphia stack in March. The plaintiff suffered severe internal bleeding allegedly linked to the use of Xarelto. The victim challenged the defendants' use of clinical trials to represent to the FDA that the drug was safe. These were serious allegations.

In order to set the stage for a discussion of the clinical trial claims, an explanation of the purposes for which Xarelto was approved would be in order. Xarelto (rivaroxaban) is FDA-approved for the following purposes:

To reduce the risk of deep vein thrombosis, or DVT, and pulmonary embolism, or PE, that might occur following knee replacement or hip replacement surgery

To actually treat DVT and PE and to reduce their recurrence following initial treatment

To reduce the risk of stroke in people who have a type of abnormal heart rhythm called non-valvular atrial fibrillation

"The initial approval of Xarelto for the prophylaxis of DVT and PE in patients undergoing hip replacement or knee replacement surgeries was based on a series of clinical trials known as the Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism studies (the "RECORD" studies)," the complaint reads in regard to the first of three clinical trials. "The findings of the RECORD studies showed that rivaroxaban was superior to enoxaparin for thromboprophylaxis after total knee and hip arthroplasty (based on the Defendants' definition), and that use of these two treatments was accompanied by similar rates of bleeding. However, the RECORD studies also showed a greater incidence of bleeding, with Xarelto, leading to decreased hemoglobin levels and the need for blood transfusion."

In regard to the second clinical trial, the Xarelto victim alleged the following: "The FDA approval of Xarelto for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation in the U.S. was based on a clinical trial known as the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation study (the "ROCKET AF" study). The ROCKET AF study's findings showed that rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation, with a similar risk of major bleeding. However, bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion."

Addressing the manufacturer's use of the third clinical trial, the plaintiff made another claim about key safety information that somehow was overlooked.

"Approval of Xarelto for the treatment of DVT and/or PE and the reduction in recurrence of DVT and/or PE in the U.S. was based on the clinical trials known as the EINSTEIN-DVT, EINSTEIN-PE, and EINSTEIN-Extension studies," the product liability lawsuit claims. "The EINSTEIN-DVT study tested Xarelto versus a placebo, and merely determined that Xarelto offered an option for treatment of DVT, with obvious increased risk of bleeding events as compared to placebo. The EINSTEIN-Extension study confirmed that result. The EINSTEIN-PE study's findings showed that a rivaroxaban regimen was non-inferior to the standard therapy for initial and long-term treatment of PE. However, the studies also demonstrated an increased risk of adverse events with Xarelto, including those that resulted in permanent discontinuation of Xarelto or prolonged hospitalization."

There was good news and bad news in those clinical trials, from a drug maker's standpoint. But, here is the Xarelto bleeding victim's point: "Defendants' marketing and promotional materials failed to similarly highlight the increased risk set forth in the results of the ROCKET AF, RECORD and EINSTEIN studies of gastrointestinal bleeding and bleeding that required blood transfusions, among other serious bleeding concerns ... As a proximate result of Defendants' negligent and reckless acts and omissions, Plaintiff suffered gastrointestinal bleeding requiring blood transfusion resulting from his ingestion of Xarelto."

The victim claims that the injuries will have lingering physical consequences into the future.

Xarelto victims deserve justice, and the experienced product liability attorneys at Reich & Binstock are fighting for just compensation for the Xarelto victims that they represent. Reich & Binstock, which since 1984 has been taking on the big pharmaceutical corporations for the injuries linked to their drugs, will evaluate an apparent Xarelto victim's case at no cost.

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